Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1598-2022·Announced 2022-08-31

Strep A Test Kits Recalled for Potential Temperature Damage

Multiple Strep A diagnostic test kits are being recalled due to temperature exposure during manufacturing and storage that may have compromised test accuracy. All lots received between June 1 and September 30, 2021 are affected.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is a Class II recall with no reported illnesses or injuries. The temperature exposure that may have affected test effectiveness represents a theoretical risk, making this a precautionary recall rather than a confirmed harm scenario.

Plain-English summary

Multiple Strep A diagnostic test kits are being recalled due to exposure to higher temperatures during storage and shipment. The affected products include test kits from McKesson Medical-Surgical, QUIDEL, Alere, Quickvue, and Abbott.

Between June and August 2021, these products were exposed to higher than normal temperatures at manufacturing and storage facilities prior to delivery. This temperature exposure may have impacted the effectiveness of the test kits, affecting their ability to accurately detect strep A infections.

All lots received between June 1, 2021 and September 30, 2021 are included in this recall. The products were distributed nationwide across the United States.

Healthcare providers and facilities using these test kits should verify their inventory against affected lot numbers and contact their distributors for replacement kits or disposal guidance.

The recalled product

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.…
Manufacturer: Mckesson Medical-Surgical Inc. Corporate Office
Category: Medical Device — Diagnostic Test / Strep A
Hazard: temperature-damage
test-inaccuracy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

GTIN: a. 00612479240100
00612479202733. b. 30014613202745. c. 00612479202726
612479240094. d. 30014613003458. e. 10815845020031
00815845020034.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 55 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 55 products in this recall →

Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office

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Same hazard · temperature damage