Z-2468-2020Class II

ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 -

Name: Z-2468-2020 ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 -
Creator: Radiometer Medical ApS
Published: 2020-05-11
License: https://open.fda.gov/license/

Radiometer Medical ApS / initiated 2020-05-11 / Terminated / root cause: labeling and UDI

FDA source

Radiometer Medical ApS began a recall of ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient... on 2020-05-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2468-2020
Classification: Class II
Status: Terminated
Initiated: 2020-05-11
Posted: 2020-06-29
Terminated: 2023-02-24
Recalling firm: Radiometer Medical ApS
Product: ABL80-FLEX CO-OX 393-841 Box Label, REF 393-841, IVD, CE, UDI: 05700693938417 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm will send consignees Urgent Medical Device Recall Letter dated 5/11/2020 via email and FedEx 2nd day delivery with proof of delivery on 5/11/2020 informing them that Radiometer has become aware that the internal barcode reader, included in every ABL80 FLEX Series analyzers, may potentially misinterpret the contents of a locally printed barcode label used for entering patient ID or accession number into the analyzer in connection with a sample measurement. The issue identified only relates to barcode types not using a check digit. A check digit enables the barcode reader to validate the data read, and hence, to capture if the barcode has been misinterpreted and consequently to reject such data. For barcodes without a check digit, the following factors may add to the risk of misinterpretation: " Poor paper quality " Poor printer quality " Improper handling of the barcode (e.g. the barcode is folded or exposed to liquid) Radiometer uses only barcode types with a check digit when producing barcode labels used for e.g. sampler identification. They request customers to take the following actions: Check if their institution is using barcode types without a check digit, including e.g. patient ID or accession number, to be read on the ABL80. 1. If you use barcode types without a check digit, Radiometer recommends to either: o Enable the check digit on the barcode type currently used, or o Change the type of barcode to one that includes a check digit, as this enables the barcode reader to validate the data read, and hence, to recognize if the barcode has been misinterpreted and consequently to reject such data.2. If you use barcode types with a check digit, the barcode reader already validates the data read and is able to identify if the barcode has been misinterpreted and consequently rejects such data. Hence, no short-term action is required. 3. If you do not use locally generated barcodes to be read by the ABL80, no short-term action is required.
Quantity in commerce: 1981
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AK, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of CA.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2468-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2467-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-29
Z-2468-2020	Class II	Terminated	Voluntary: Firm initiated	2020-07-08	2020-06-29

Product code CHL

K080370Class IIAbl 80 Co-Ox SystemSendx Medical, Inc. / cleared 2008-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)