Device Recall VITROS (R) Chemistry Products FS Calibrator 1 의 리콜

Recall

68286

Class 2

Z-1805-2014

2014-05-12

2014-06-16

Terminated

United States

2017-03-23

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127271

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.

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.