Life Technologies Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use recall — FDA Z-0173-2019
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
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.
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
The product was mislabeled as containing the incorrect type of suture.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be…
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be…
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and…
The catheter failed the endotoxin testing.
Leaky bottles due to a defect in the bottle cap compromising the sterility of the product
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Reports of circulatory support system motor stopping. Motor stop can be attributed to a break of a wire or short circuit between wires within the electrical cable where the cable exits the…
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and…
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Some of the Disposable Smooth Interior Tubing may pull apart when stretched.
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
Atellica Solution system software (SW) version 1.13 and lower, five (5) behavioral issues were identified: 1. Reagent Lock may not work as intended with Primary Reagent ReadyPacks and…
There were complaints indicating that when the product was opened in surgery, the sterile packaging was already open.
The firm has identified performance anomalies with the device caused when more than 64 TD60 telemetry transmitters have been connected to a central station. The anomaly causes some ECG…
Browse recent months with enough recall history for useful comparison.