Roche Recalls Elecsys BRAHMS PCT Immunoassay Due to Decreased Sample Recovery
Roche Diagnostics is recalling 47 units of the Elecsys BRAHMS PCT Immunoassay because it shows decreased recovery of patient samples on the cobas e 801 module compared to other analyzers.
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: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text describes a performance defect (decreased recovery) without reporting any specific injuries, illnesses, or fatalities, aligning with a Moderate severity rating for a diagnostic device.
Plain-English summary
Roche Diagnostics Corporation is recalling 47 units of the Elecsys BRAHMS PCT Immunoassay. This product is used for the in vitro quantitative determination of procalcitonin (PCT) in human serum and plasma. The recall is limited to Lot number 204084.
The recall was initiated because the product exhibits a decreased recovery of patient samples when used on the cobas e 801 module. This performance issue was observed in comparison to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.
The affected units were distributed in the United States to the states of California, Florida, and Indiana. Healthcare facilities and laboratories that have received this specific lot number should stop using the product and contact Roche Diagnostics for further instructions.
The recalled product
- Product
- Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
- Manufacturer
- Roche Diagnostics Corporation
- Hazard
- Affected units
- 47
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 (1)
- Elecsys BRAHMS PCT: 07301715190 Lot number 204084
Distribution
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