Alere Recalls hCG Pregnancy Tests Due to False Positive Risk
Alere San Diego, Inc. is recalling multiple hCG pregnancy test models because they may detect low hCG levels, resulting in false positive results.
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: The recall is classified as FDA Class II, and the hazard involves a diagnostic error (false positive) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Alere San Diego, Inc. is recalling several models of hCG rapid pregnancy tests, including Fisher Scientific Sure-Vue, Beckman Coulter ICON 25, Henry Schein One Step+, Alere hCG Combo Cassette, and Pro Advantage By NDC. The recall affects 5,331,585 units distributed worldwide, including nationwide in the United States and in various international countries.
The recall is being issued because the hCG rapid tests may detect low levels of human chorionic gonadotropin (hCG) below the stated assay sensitivity. This defect may result in false positive results, potentially leading to incorrect medical conclusions regarding pregnancy status.
Consumers and healthcare providers should stop using the affected devices and contact the recalling firm for instructions on return or replacement. The specific models and lot information are detailed in the official recall notice.
The recalled product
- Product
- Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529, FHC-202/23900528; Beckman Coulter Inc's ICON 25 hCG, Model/ Part: FHC-202/43025; Henry Schein One Step+ hCG Combo test in Serum or Urine, Model/ Part: FHC-202/9004075; Alere hCG Combo Cassette…
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 5,331,585
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 (9)
- 2018-01-15
- 23900528/00613647000564/1155810906
- 43025/15099590776886/May 2015
- 9004075/10304040024123/1155875804
- 2014-06-09
- 92225/10815845020116/1156015603
- 07/16
- P080021/M220P0800213/40001856
- 2023-03-30
Distribution
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