Complete FDA and NHTSA recall records dated in April 2021.
These records include useful source details for the selected month.
It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the…
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector…
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Interference condition between the 10mm Drill Guide Inserter and the inner shaft that mates with the inserters. As a result, inner shafts do not mate flush with the collet inserters, and…
Discoloration and turbidity were present in the specified lots of STMs because of Longer Monsoon season at the South Korean Manufacturing Facility.
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
bioMerieux received complaints about calibration issue observed on several lots of VIDAS CMV IgM (ref 30205 ; 30205-01).
Verification and validation of the virus transport medium tubes was not provided to FDA prior to sale and marketing
Possible false negative or false positive results due to the product being compromised during shipment.
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential for the device safety interlock to fail. The safety interlock prevents an empty single-use reload from being erroneously fired a second time. If the safety interlock fails and the…
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on…
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
