Reported Aug 31, 2022 · Ongoing
Strep test
Mckesson Medical-Surgical Inc. Corporate Office
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mckesson Medical-Surgical Inc. Corporate Office · 9954 Maryland Drive · Richmond, VA · 23233
Is this the product you have?
Strep test
5 of 5 products
| Model / number | Product as published |
|---|---|
5003. | McKesson Medical-Surgical McKesson Rapid Test Kit McKesson Consult Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests |
20274. | QUIDEL Sofia TEST KIT, STREP A+ SOFIA (25/KT 12KT/CS) |
4999. | Alere SAN DIEGO INC McKesson TEST, KIT STREP A DIPSTICK WAIVED (50/KT) Exempt |
00345. | In-Line Control Swab Quickvue In-Line Strep A Test Positive Level / Negative Level 12 Swabs (IVD) |
92001 | (added 11/30/22) Abbott Rapid Test Kit Acceava Infectious Disease Immunoassay Strep A Test Throat Swab Sample 50 Tests |
- Lot codes and dates
- GTINa. 00612479240100; 00612479202733. b. 30014613202745. c. 00612479202726; 612479240094. d. 30014613003458. e. 10815845020031, 00815845020034
- Amount recalled
- a. 214 kits b. 1cs c. 53 kits d. 4 bx e. 1 KT
This recall covers 55 products
The agency filed one notice per product. You are reading one of them; the other 54 are below.
42 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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