Summary
The FDA issued a Class II for ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 by Radiometer Medical ApS. Reason: There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+..
Details
Source
Device Recall
External ID
Z-1321-2022
Action Date
2022-07-13
Status
Ongoing
Category
device
Product Description
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Lot/Code Info: All ABL800 Flex Analyzers containing software versions below V6.19 MR2; UDI/DI ABL810, 820, and 830, ABL805, ABL815, ABL825, ABL835: 05700693938004 ; UDI/DI ABL817, ABL827, ABL837: 05700693938011
Quantity Affected: 1489 analyzers
Reason for Recall
There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AR, 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, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Bermuda, Canada, Italy, Norway, Austria, Afghanistan, Albania, Algeria, Argentina, Bahrain, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Cuba, Cyprus, Ecuador, Egypt, Eritrea, Ethiopia, Greece, Guatemala, Honduras, Iraq, Israel, Jamaica, Jordan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malta, Mauritius, Moldova, Nepal, Nicaragua, Nigeria, Oman, Pakistan, Paraguay, Peru, Philippines, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Slovenia, Sri Lanka, Suriname, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Uganda, Ukraine, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe, China, Croatia, Denmark, Iceland, Germany, Spain, Portugal, India, Brunei, Japan, United Kingdom, Ireland, Russia, Hungary, Australia, New Zealand, Tokelau, Switzerland, France, Czech Republic, Slovakia, South Africa, Botswana, Namibia, Poland, Turkey, Sweden, Finland, Estonia, Kazakhstan, Malaysia, Hong Kong, Mexico, South Korea, Singapore.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-05-18
Company
Bronshoj, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 120 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Radiometer Medical ApS has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Radiometer Medical ApS) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Radiometer Medical ApS have FDA actions?
Radiometer Medical ApS has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1321-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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