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U.S. Department of Health and Human Services

Class 2 Device Recall Ortho

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  Class 2 Device Recall Ortho see related information
Date Initiated by Firm March 25, 2022
Create Date May 18, 2022
Recall Status1 Open3, Classified
Recall Number Z-1112-2022
Recall Event ID 90047
510(K)Number K964720  
Product Classification Radioimmunoassay, follicle-stimulating hormone - Product Code CGJ
Product VITROS Immunodiagnostic Products FSH Reagent Pack- IVD
1931922
Code Information Until further notice, future lots will also be affected. UDI: 10758750000302 Affected Lot Number/ Expiration Date: 3100 01-MAR-2022; 3111 25-MAR-2022; 3120 04-APR-2022; 3130 25-APR-2022; 3140 10-MAY-2022; 3145 10-MAY-2022; 3150 30-MAY-2022; 3160 09-JUN-2022; 3170 22-JUN-2022; 3180 02-AUG-2022; 3190 16-AUG-2022; 3200 06-SEP-2022; 3210 12-SEP-2022.
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc
1001 Us Highway 202
Raritan NJ 08869-1424
For Additional Information Contact SAME
908-218-8776
Manufacturer Reason
for Recall		 Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
FDA Determined
Cause 2		 Device Design
Action Ortho CLinical Diagnostics issued "URGENT PRODUCT CORRECTION NOTIFICATION" dated 3/25/22 to consignees who had been shipped VITROS FSH, LH or Prol in the previous 18 months were notified (CL2022-069) of the issue and instructed as follows: -Run daily low-level QC in duplicate to confirm acceptable performance. -If their laboratory is experiencing low end imprecision with VITROS FSH, LH or Prol Reagent, follow one of the suggested testing algorithms as described in the enclosure. o Note: If their laboratory is not experiencing low end imprecision, continue testing patient samples as usual (single replicate). -Until further notice, all future lots of the products will also be affected. -On the enclosed Credit Form, track the additional quantities of VITROS FSH, LH and/or Prol tests used due to the testing protocol. Periodically submit the form to Ortho. Ortho will credit their account. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in Commerce 2502 total: 2154 US; 348 OUS
Distribution Worldwide Distribution: US (Nationwide) OUS (Foreign): Australia Bermuda Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Netherlands Norway Portugal Russia Singapore Spain Sweden United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CGJ and Original Applicant = JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
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