Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall ABL90 FLEX

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall ABL90 FLEX see related information
Date Initiated by Firm November 21, 2019
Create Date May 28, 2020
Recall Status1 Open3, Classified
Recall Number Z-2139-2020
Recall Event ID 85390
510(K)Number K092686  
Product Classification Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
Product ABL90 FLEX, model no. 393-090; 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 Model no. 393-090: R0659 - R0977 and Spare Part Hemolyzer Units (902-980): R0526 - R0941
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 2		 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 1233 units
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CHL and Original Applicant = RADIOMETER MEDICAL APS
-
-