Siemens Healthcare Diagnostics ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US recall — FDA Z-1393-2021
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
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
Potential Sample Identification (SID) Mismatch with14-Character Barcodes
The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional laminate layer in the package…
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…
The firm was notified by their contract manufacture that the product contains undeclared hazelnuts.
Undeclared hazelnut in Chocolate Truffles cake topping.
Wasabi Flavor Seaweed snack is incorrectly packaged in Original Seaweed Flavor package which does not declare FD&C Yellow 5 and FD&C Blue No 1.
Presence of E. coli species
CGMP Deviations
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the…
Browse recent months with enough recall history for useful comparison.