VITROS Immunodiagnostic Products CK-MB Calibrators, REF 128 6293, IVD, Ortho-Clinical Diagnostics High Wycombe HP12 4DP,
FDA device recall Z-1337-2013 · posted 2013-05-17 · Terminated
Recall details
- Recalling firm
- Ortho-Clinical Diagnostics
- Reason for recall
- Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20 degrees Celsius (-4 degrees Farenheit) generated invalid calibrations that were detected by positively biased quality control results.
- Action taken
- Ortho Clinical Diagnostic sent a " Important Product Correction Notification" letter dated April 3, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were informed of the issue and advised they must discontinue storage of opened-reconstituted vials of VITROS CK-MB Calibrators frozen at -20 degrees Celsius (-4 degrees Farenheit). The same day, the Distributor letters were sent via US Postal Service Priority Mail or FedEx overnight courier to US Distributor consignees who were informed of the issue and instructed to notify their customers of the issue and actions. Also on April 3, 2013, the foreign affiliates were informed of the issue by e-mail and instructed to notify their consignees of the issue and actions. Confirmation of Receipt - Important Response Required so that we can complete our records, please return this form to us no later than April 19, 2013. FAX: 1-888-557-3759 or 1-585-453-4110 We apologize for any inconvenience this may have caused your laboratory. If you have any additional questions, please call Customer Technical Services at 1-800-421-3311.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JIX
- Quantity affected
- Domestic: 3019 units, Foreign: 905 units
- Distribution
- Worldwide Distribution - Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panam
- Date initiated
- 2013-04-03
- Date posted
- 2013-05-17
- Date terminated
- 2017-03-02
- Location
- Rochester, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) (K973030) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-09-04 |