Roche cobas b 123 Fluid Pack Recall for Low PO2 Results
Roche is recalling 82 cobas b 123 Fluid Packs due to a calibration issue that may cause erroneously low PO2 results in patient samples.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (erroneously low PO2 results) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 82 units of the cobas b 123 Fluid Pack COOX (Catalog 05169992001). The affected lots are 21446113, 21446123, 21446153, 21446183, and 21446203, with expiration dates ranging from August 8, 2015, to October 1, 2015.
The recall was initiated because of a calibration issue with the PO2 parameter that causes quality control failures. This issue may not be detected because QC results can fall below mean values while still remaining within 2 standard deviation limits. The defect creates a potential for erroneously low PO2 results in patient samples, particularly in blood samples with PO2 values below 50 mmHg.
The product was distributed nationwide in the states of Louisiana, South Carolina, California, Texas, Nebraska, Virginia, and West Virginia, as well as in Puerto Rico. Healthcare facilities should stop using the affected fluid packs and contact Roche Diagnostics for further instructions.
The recalled product
- Product
- cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglob
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 82
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 (6)
- cobas b 123 Fluid Pack COOx Catalog 05169992001
- lot numbers 21446113 (exp 8/8/2015)
- 21446123 (exp 8/18/2015)
- 21446153 ( exp 9/18/2015)
- 21446183 (exp 9/19/2015)
- and 21446203 (exp 10/01/2015)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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