A software malfunction was found where WBC, RBC and PLT comments added after a slide is signed, are not sent to the LIS. This can only occur where customers process multiple slides per blood sample.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass
Maquet Cardiopulmonary Ag
Class I - Dangerous
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
Class I - Dangerous
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
Class I - Dangerous
In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.
Class I - Dangerous
There is a potential for the patient port retaining ring to not fully seat allowing the patient port to detach during use. This may impact air delivery to the patient.
RS 5F DL BIOFLO PASV, Catalog Number 60M181578
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
RS 5F DL BIOFLO PICC, Catalog Number 60M071831
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
DermaPro Waterproof Silicone Tape, SNS57232
Safe N Simple
Class I - Dangerous
The recalling firm received a customer complaint stating the tape was difficult to peel off the roll and had poor adhesion.
Class I - Dangerous
One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification.
Class I - Dangerous
The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value.
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, Catalog Number 45-871
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
XCELA PASV 5F SL 55CM IR-145 Nitinol Wire KIT PG, Catalog Number 25-124
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Bio-Stable 5F SL-55CM IR-145 Kit Valved with Nitinol GW PG, Catalog Number 45-882
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
RS 5F DL XPP KIT, Catalog Number 60M183104
Angiodynamics Inc. (Navilyst Medical Inc.)
Class I - Dangerous
A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detected once inserted, or biased results, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result.