Z-2138-2020Class II

ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 -

Name: Z-2138-2020 ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 -
Creator: Radiometer Medical ApS
Published: 2019-11-21
License: https://open.fda.gov/license/

Radiometer Medical ApS / initiated 2019-11-21 / Terminated / root cause: manufacturing process

FDA source

Radiometer Medical ApS began a recall of ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists... on 2019-11-21. FDA classified it as Class II and gives the reason as "The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2138-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-21
Posted: 2020-05-28
Terminated: 2024-11-08
Recalling firm: Radiometer Medical ApS
Product: ABL90 FLEX PLUS, model no. 393-02; and Spare Part Hemolyzer Units (902-980): R0526 - R0941 - Product Usage: are intended for use by trained technologists, nurses, physicians and therapists. 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: The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Two Urgent Medical Device Recall Letters were sent to customers at the user level via email followed by a hard copy letter sent FedEx 2nd day with tracking and proof of delivery. The first letter, dated 11-21-2019, was intended for customers not utilizing the analyzer for measuring blood samples from newborn babies of up to four weeks of age. The letter informed customers of biased results for tbil, that the bias increases with tHb concentration, and that the increase is not linear. Customers were informed of the potential risks to patients, and were requested to complete the Recall Response Form with hospital name, serial numbers of affected devices, and to indicate whether or not the device(s) is/are used for measuring blood samples from newborn babies of up to four weeks of age and tBil is actually reported, or if the device(s) is/are no longer in use. Response forms were requested to be sent by fax or email to their Radiometer Representative (Fax No.: 714 582 0806; Email: [email protected]). Customers were informed that their local Radiometer representative would, in conjunction with a future planned visit, check if the customers' analyzer includes an affected hemolyzer unit, and if so, exchange the hemolyzer unit. Customers who are not end users of the device were requested to ensure that this letter was distributed to the final end-user. Customers with questions were instructed to contact their Radiometer representative. The second letter, also dated 11-21-2019, was intended for customers using the analyzer for measuring blood samples from newborn babies of up to four weeks of age, where total Bilirubin (tBi)l is actually reported. This letter also informed customers of the bias increases with tHb concentration, and that the increase is not linear. Risks for newborn babies up to four weeks were described. Customers were requested to take one of two actions until Radiometer had developed a solution for this issue. Choice of interim actions incl
Quantity in commerce: 544
Distribution: Worldwide distribution - US Nationwide. Also distributed OUS.
Product codes and lots: ABL90 FLEX PLUS Model no. 393-092: R0014 - R0195; and Spare Part Hemolyzer Units (902-980): R0526 - R0941; Model Number 393-092.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2138-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2138-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28
Z-2139-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-28

Product code CHL

K160153Class IIAbl90 Flex PlusRadiometer Medical Aps / cleared 2016-11-04

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)