VITROS Chemistry Products PHBR recall
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and…
Why was VITROS Chemistry Products PHBR recalled?
Ortho Clinical Diagnostics (OCD) received customer complaints of intermittent imprecision, outliers, or shifts in accuracy and control fluid values outside of expected intervals when using VITROS Chemistry Products PHBR Slides. OCD's investigation confirmed that positively biased values for patient samples could be obtained that may not be detected by quality control fluids.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, Expiration Date Range 12/01/13 through 02/01/14. [A Coating (CTG) is a unique identifier within the Lot Number of some of OCD's products. The term GEN and CTG refer to a specific segments of the reagent lot number. Current lots within expiry were all from Coatings 0060, 0062, 0063 or 0064.].
- Product
- VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- Domestic: 11,164 units, Foreign: 594 units
- Distribution
- Worldwide Distribution-USA (nationwide) and Puerto Rico and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela.
- Recall date
- May 1, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)