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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Event Detail

Event ID 64707
Product Type Devices
Status Ongoing
Recalling Firm Ortho-Clinical Diagnostics
City Rochester
State NY
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-14
Initial Firm Notification of
Consignee or Public
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma. 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.]. Class II 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. Domestic: 11,164 units, Foreign: 594 units Z-1152-2013