Z-1312-2024Class II

Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG)...

Name: Z-1312-2024 Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG)...
Creator: Mckesson Medical-Surgical Inc. Corporate Office
Published: 2024-01-09
License: https://open.fda.gov/license/

Mckesson Medical-Surgical Inc. Corporate Office / initiated 2024-01-09 / Open, Classified

FDA source

Mckesson Medical-Surgical Inc. Corporate Office began a recall of Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL on 2024-01-09. FDA classified it as Class II and gives the reason as "Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1312-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-09
Posted: 2024-03-19
Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Product: Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Reason for recall: Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
FDA root cause: Storage
Action: McKesson notified customers by phone January 9, 2024 with a follow-up call January 17, 2024 instructing customers of three scenarios based upon the products they received and the investigation in conjunction with relevant manufacturer. The firm also sent Urgent Product Recall Notifications via email on February 8, 2024 instructing customers to immediately examine inventory and quarantine all affected devices, complete and return the provided response form to [email protected], and notify customers who you have further distributed recalled devices to of this recall and to segregate and quarantine any devices they have on hand. Replacement products will be provided and may have the same lot number(s) as the recalled items but are not affected by the recall and are acceptable for use. Customers with questions can contact McKesson directly by phone at (800) 688-8840. Representatives are available Monday to Friday, 8:00 am to 5:00 pm PST.
Quantity in commerce: 3 units
Distribution: US Nationwide distribution in the states of AZ, PA and TX.
Product codes and lots: Catalogue Number: 5011; UDI/DI: 612479202788; Lot No. KN00589;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1312-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1311-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19
Z-1312-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19
Z-1313-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19
Z-1314-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19
Z-1315-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19

Product code JJX

K050328Class IPregnancy-SkreenBiochemical Diagnostic, Inc. / cleared 2005-03-29

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)