Ortho-Clinical Diagnostics Recalls VITROS Phenobarbital Slides Due to Accuracy Issues
Ortho-Clinical Diagnostics is recalling VITROS Phenobarbital Slides because they may produce inaccurate, positively biased patient results that quality controls might miss.
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 involves a medical device that may produce inaccurate diagnostic results (positively biased values) which could lead to incorrect patient management. This fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ortho-Clinical Diagnostics (OCD) is recalling VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. These products are used for the quantitative measure of phenobarbital concentration in serum and plasma. The recall affects 11,164 domestic units and 594 foreign units distributed worldwide, including the United States, Puerto Rico, and various international markets.
The recall was initiated after OCD received customer complaints regarding intermittent imprecision, outliers, or shifts in accuracy, as well as control fluid values falling outside expected intervals. OCD's investigation confirmed that the slides could produce positively biased values for patient samples. The company noted that these inaccuracies may not be detected by standard quality control fluids.
The affected lots are identified by specific generation and coating numbers with expiration dates ranging from March 2013 to February 2014. Specifically, the recall includes lots with GEN 38 (Coating 0060), GEN 39 (Coating 0062), GEN 40 (Coating 0063), and GEN 41 (Coating 0064). Users of these products should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
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 (13)
- All Lot Numbers containing: GEN 38
- Coating No. 0060
- Expiration Date Range 03/01/13 through 07/01/13
- GEN 39
- Coating No. 0062
- Expiration Date Range 07/01/13 through 09/01/13
- GEN 40
- Coating No. 0063
- Expiration Date Range 10/01/13 through 12/01/13
- GEN 41
- Coating No. 0064
- 0062
- 0063 or 0064.].
Distribution
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