Class 2 Device Recall ABL90 FLEX PLUS

• Date Initiated by Firm: November 21, 2019
• Create Date: May 28, 2020
• Recall Status: Terminated on November 08, 2024
• Recall Number: Z-2138-2020
• Recall Event ID: 85390
• 510(K)Number: K160153
• Product Classification: Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
• 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.
• Code Information: ABL90 FLEX PLUS Model no. 393-092: R0014 - R0195; and Spare Part Hemolyzer Units (902-980): R0526 - R0941; Model Number 393-092.
• Recalling Firm/ Manufacturer: Radiometer Medical ApS; Akandevej 21; Bronshoj Denmark
• Manufacturer 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.
• FDA Determined 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: RECALL@RADIOMETERAMERICA.COM). 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CHL