Alere Fertility Test Pregnancy Test Kits Recalled Due to Temperature Damage
Alere Fertility Test pregnancy test kits distributed in the US have been recalled because temperature excursions during storage may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves pregnancy test kits with potential reduced effectiveness due to temperature damage. No illnesses, injuries, or deaths have been reported; the hazard is theoretical based on potential product degradation. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Alere Fertility Test hCG pregnancy test kits (Models 92210 and 92211) have been recalled. These rapid test kits detect human chorionic gonadotropin in urine samples and are packaged in boxes of 30 or 50 tests.
Between June and August 2021, temperature excursions at the facility storing these products prior to delivery exposed them to higher than normal temperatures. This thermal exposure may have reduced the effectiveness of the pregnancy test kits.
The recall affects all lots of these models distributed to US locations between June 1 and September 30, 2021. The recalled GTINs are 10815845020130, 00815845020133 (Model 92210) and 10815845020093, 00815845020096 (Model 92211).
The recalled product
- Product
- a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Num
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- product-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: a. 10815845020130
- 00815845020133. b. 10815845020093
- 00815845020096
Distribution
Distributed nationwide across the United States.
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