Z-1598-2022Class II

Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease...

Name: Z-1598-2022 Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease...
Creator: Mckesson Medical-Surgical Inc. Corporate Office
Published: 2022-05-25
License: https://open.fda.gov/license/

Mckesson Medical-Surgical Inc. Corporate Office / initiated 2022-05-25 / Open, Classified / root cause: manufacturing process

FDA source

Mckesson Medical-Surgical Inc. Corporate Office began a recall of Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25... on 2022-05-25. FDA classified it as Class II and gives the reason as "Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1598-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-25
Posted: 2022-08-26
Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Product: Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests, Model Number: 5003. b. QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) Model Number: 20274. c. Alere SAN DIEGO INC McKesson TEST, KIT STREP A DIPSTICK WAIVED (50/KT) Exempt Catalog #4999. d. In-Line Control Swab Quickvue In-Line Strep A Test Positive Level / Negative Level 12 Swabs (IVD) Catalog # 00345. e. (added 11/30/22) Abbott Rapid Test Kit Acceava Infectious Disease Immunoassay Strep A Test Throat Swab Sample 50 Tests, Model Number: 92001
Product code: GTY Antigens, All Groups, Streptococcus Spp.
Reason for recall: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: Mckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle) Sedgwick, Memphis, TN 38120 [email protected]. from May 10, 2022 continuing through July 21, 2022. Letter states: If you have further distributed this product, please notify your patients at once of this product recall. Your notification to your patients may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent possible patient harm. Please complete and return the enclosed response form as soon as possible even if you do not have any product on hand. Customers should contact Sedgwick directly by phone at 1-888-943-2401 to return the recalled products or if they have additional questions regarding this notification. Representatives are available Monday Friday, 8:00 am 5:00 pm PT
Quantity in commerce: a. 214 kits b. 1cs c. 53 kits d. 4 bx e. 1 KT
Distribution: US Nationwide
Product codes and lots: GTIN: a. 00612479240100; 00612479202733. b. 30014613202745. c. 00612479202726; 612479240094. d. 30014613003458. e. 10815845020031, 00815845020034.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1598-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1583-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1584-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1585-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1586-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1587-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1588-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1589-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1590-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1591-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1592-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1593-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1594-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1595-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1596-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1597-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1598-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1599-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1600-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1601-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1602-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1603-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1604-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1605-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1606-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1607-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1608-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1609-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1610-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1611-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1612-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1613-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1614-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1615-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1616-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1617-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1618-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1619-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1620-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1621-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1622-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1623-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1624-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1625-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1626-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1627-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1628-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1629-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1630-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1631-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1632-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1633-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1634-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1635-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1636-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25
Z-1637-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-31	2022-08-25

Product code GTY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)