Recall record at a glance
| Official record | Z-1800-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Completed |
| Recalling firm | Bio-Rad Labs |
| Report date | May 6, 2020 |
| Recall initiation date | Apr 3, 2019 |
| Quantity | 376 units |
| Location | Benicia, CA, United States |
Official product description
Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.
Why the product was recalled
An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between these two lots is largely due to samples with higher levels of antibodies. With the cut-off for the assay being 15 U/mL, the clinical classifications for most samples would remain unchanged.
Distribution information
US Nationwide distribution including the states of AZ, NY, LA, FL, CA, TX, IA, MS, UT, and IL.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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