Abl 80 Co-Ox System

510(k) K080370

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK080370	Date31 Jul 2008Cleared	StatusActive

4 recalls · FDA

- Terminated Z-2468-2020 FDA Class II initiated 11 May 2020
Barcode readers on ALB900 and ABL800 analyzers used for measuring pH, blood gases, electrolytes, glucose, lactate, hematocrit and oximetry may misinterpret the contents of some barcode types not using a check digit for patient ID or accession number. Misinterpretation of a barcode, including e.g. patient ID or accession number, may result in patient mix up and/or delayed medical treatment.
- Terminated Z-2304-2012 FDA Class II initiated 6 Jun 2012
The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.
- Terminated Z-0195-2013 FDA Class II initiated 6 Jan 2010
The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters.
- Terminated Z-0150-2010 FDA Unclassified (pre-2012) initiated 20 Feb 2009
Inverness have recently become aware of a potential error contained in V1.30 and V1.31 software for the ABL 80 CO-OX platform. The error can occur if the analyzer is set to automatically upload patient records to Radiance or an HIS/LIS system. This can result in the reporting of incorrect results for one or more CO-OX derived parameters. Incorrect results can be displayed on the screen and the

1 jurisdiction

United States — FDA 510(k) Active

510(k)