Roche Recalls Cobas b 123 Fluid Pack Cuvettes Due to Thickness Defect
Roche Diagnostics is recalling specific lots of Cobas b 123 Fluid Pack COOX cuvettes because a production error caused a change in layer thickness, leading to a higher failure rate.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a functional defect (increased failure rate) rather than a direct safety risk like contamination or structural failure, fitting the criteria for a moderate severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 23 units of Cobas b 123 Fluid Pack COOX cuvettes. The affected products are identified by lot numbers 21426121 and 21426171 and part number 05169992001. These cuvettes are used in the Cobas b 123 POC system for in vitro measurement of blood parameters.
The recall was initiated because the cuvettes exhibit a significant increase in the out-of-box failure rate. Internal investigations determined that this issue was caused by a change in the thickness of the cuvette layer, which resulted from production equipment settings. Although the cuvettes were produced within specifications, they fell within the upper limits of the allowable range.
The affected units were distributed nationwide, including in New England and Arizona. Users of the Cobas b 123 POC system should check their inventory for the specific lot numbers listed and stop using the affected cuvettes.
The recalled product
- Product
- Cobas b 123 POC system cobas b 123 POC system is fully automated POC system for whole blood in vitro measurement of pH, blood gases (BG), electrolytes Na+ K+, iCa2+ (ISE), hematocrit (Hct), metabolites (Gluc, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHB, COH
- Manufacturer
- Roche Diagnostics Operations, Inc.
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 (2)
- Part number: 05169992001 cobas b 123 Fluid Pack COOX
- 200 with Lot# 21426121 and Lot# 21426171.
Distribution
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