Medical device recall: sterilization validator with incorrect incubation time
TERRAGENE S.A. is recalling 914 ASP BIOTRACE Auto Read 60 sterilization process challenge devices due to incorrect incubation time listed in the product instructions. The IFU lists 20 minutes instead of the correct 60 minutes.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involving an instruction error in the product documentation. No illnesses, injuries, or deaths have been reported. The hazard is theoretical—related to potential improper sterilization validation—but lacks confirmed incidents of harm.
Plain-English summary
TERRAGENE S.A. is recalling the ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device (REF 73135) distributed nationwide in the United States, specifically in California and Kentucky. A total of 914 units are affected by this recall.
The recall was issued because the Instructions for Use (IFU) for the device contains an error: it lists an incorrect incubation time of 20 minutes instead of the correct incubation time of 60 minutes. This process challenge device is used to validate steam sterilization processes. If users follow the incorrect incubation time specified in the IFU, the sterilization process validation may not be performed correctly.
Consumers and healthcare facilities that have received this device should stop using the recalled units and contact TERRAGENE S.A. for corrected instructions or a replacement device.
The recalled product
- Product
- ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135.
- Manufacturer
- TERRAGENE S.A.
- Hazard
- Affected units
- 914
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 (8)
- Lot numbers: F40062
- F40064
- F40072
- F40074
- F40101
- F40116
- UDI-DI - 07798375772624 (primary packaging)
- 07798375772877 (secondary packaging) containing IFU Rev.A R0.
Distribution
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