McKesson Pregnancy Test Kits Recalled for Temperature Exposure During Storage
McKesson recalls hCG pregnancy test kits nationwide due to facility temperature excursions that may have compromised product effectiveness. Affected lots were received between June and September 2021.
What this means for you
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 an FDA Class II recall with a theoretical hazard (potential reduced effectiveness due to temperature exposure) and no reported illnesses or injuries. Per the severity rubric, Class II recalls without reported harm score as Moderate (2).
Plain-English summary
McKesson Medical-Surgical is recalling three models of hCG pregnancy test kits distributed nationwide. The recalled kits are Model 5002 (serum/urine sample), Model 5000 (urine sample), and Model 5001 (cassette format), totaling approximately 2,171 units.
Affected kits experienced facility temperature excursions between June and August 2021 prior to shipment. Exposure to elevated temperatures may have reduced the test's effectiveness or sensitivity. No illnesses or injuries have been reported in connection with this recall.
Consumers who possess affected lots (all lots received between June 1 and September 30, 2021) should discontinue use and contact their healthcare provider if they have questions about pregnancy test results obtained using these kits or if they need guidance on alternative testing options.
The recalled product
- Product
- a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Serum / Urine Sample 25 Tests. Model Number: 5002. b. McKesson Consult Rapid Test Kit McKesson Consult Fertility Test hCG Pregnancy Test Urine Sample 25 Tests Model Number: 5000. c. McKesso
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- reduced-effectiveness
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 (3)
- GTIN: 10612479218625
- 2021. b. GTIN: 10612479218618
- 20612479202744
Distribution
Distributed nationwide across the United States.
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