Various types of Fetal Bovine Serum Bovine sourced Animal Sera for… — Class II medical device recall Z-1735-2013
Terminated recall by Paa Laboratories Inc, reported 2013-07-24, distributed nationwide. Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine
| Recall number | Z-1735-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Paa Laboratories Inc, Etobicoke, Ontario, Canada |
| Recall initiated | 2013-04-12 |
| Classified | 2013-07-15 |
| Reported by FDA | 2013-07-24 |
| Terminated | 2015-09-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 280,000 liters |
| Reason classes | labeling |
Product
Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
Reason for recall
Current product labeling band data sheets state that FBS Pharma Grade and FBS/FBS Native are pure Fetal Bovine Serum (FBS). These products may contain added adult Bovine Serum Albumin (BSA)of United States origin, water, and/or cell growth promoting additives. All other FBS products, as listed below, including FBS Gold and FBS Standard, described as specialty sera', may contain adult BSA of Un
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1735-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.