VITROS (R) Chemistry Products FS Calibrator 1, Product Code/ Catalog Number 6801873 -- For in vitro diagnostic use only

FDA device recall Z-1805-2014 · posted 2014-06-16 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator value assignment for VITROS (R) Chemistry Products hsCRP Reagent (Product Code 6801739), Generation (GEN) 28.

Action taken

Customer Product Correction Letters (CL2014-143, dated 5/12/14) were sent on 5/12/2014 via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) and /or ORTHO PLUS e-Communications to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and advise them to discontinue use of the affected calibrator lot(s), and inform their Laboratory Medical Director if they suspect that a previously reported result may have been affected. Distributor letter (DL2014-143) was also sent on 5/12/2014 via US Postal Service Priority Mail and/or FedEx overnight courier to US Distributor consignees and instructed to notify their consignees of the issue and the required actions. Foreign affiliates were pre-notified via e-mail on 5/08/2014 that the communication of this issue and required actions is imminent and were sent the finalized recall communication on 5/12/2014.

Root cause

Process change control

Status

Terminated

Product code

DKB

Quantity affected

Domestic - 464 units; Foreign - 361 units

Distribution

Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Sin

Date initiated

2014-05-12

Date posted

2014-06-16

Date terminated

2017-03-23

Location

Rochester, NY

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