Z-1344-2013Class III

Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid...

Name: Z-1344-2013 Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid...
Creator: Alere San Diego, Inc.
Published: 2013-01-21
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2013-01-21 / Terminated / root cause: labeling and UDI

FDA source

Alere San Diego, Inc. began a recall of Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for... on 2013-01-21. FDA classified it as Class III and gives the reason as "Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1344-2013
Classification: Class III
Status: Terminated
Initiated: 2013-01-21
Posted: 2013-05-21
Terminated: 2013-08-28
Recalling firm: Alere San Diego, Inc.
Product: Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP hCG Cassette Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in the early detection of pregnancy. This test is for professional use.
Product code: JHI Visual, Pregnancy Hcg, Prescription Use
Reason for recall: Alere San Diego Inc. is recalling the Cardinal Health hCG Cassette Rapid Test because some of them were incorrectly packaged into Cardinal Health hCG Combo Rapid test kit boxes. The kit box incorrectly indicates the product may be used for both urine and serum sample types.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm, Alere, sent an "URGENT MEDICAL DEVICE RECALL" letter dated January 21, 2013 to all their customers. The letter describes the product, problems identified and the actions to be taken. Customers are instructed to discontinue use and/or sale of the product; immediately discard all units of the the product in accordance with your local regulations; share this information with your laboratory staff and retain this letter for your records; if you have forwarded the product to another laboratory, provide a copy of this letter to them and include the name, address and a contact for the laboratory on the enclosed Customer Verification Form; complete and return the Customer Verification Form within 10 days via fax to: Technical Service at 858-805-8457 or e-mail to [email protected]. Customers with any questions are instructed to contact Alere Technical Services at (866) 216-0094 or by email at [email protected].
Quantity in commerce: 2,167 kits
Distribution: Nationwide distribution: USA including states of: AL, AK, AR, AZ, CA, CO, CT, DE, HI, IA, ID, IL, IN, FL, GA, KY, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, UT, TN, TX, VA, WA, WI, WV AND WY.
Product codes and lots: Lot: hCG2080330

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1344-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1344-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-29	2013-05-21

Product code JHI

K993317Class IIAcon Hcg One Step Pregnancy Test Device (Urine)ACON Laboratories, Inc. / cleared 1999-12-01

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)