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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87870

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 14, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Radiometer Medical ApS

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

Z-1856-2021
Recall number
Z-1856-2021
Initiated
April 14, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Radiometer Medical ApS
Quantity
Total=3,346 analyzers world-wide (only 2 analyzers within the U.S.)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

Code information

Model Number: ABL90 FLEX (393-090) Serial Numbers: ABL90 FLEX analyzers with serial number R0996 R1000, and R1003 onwards

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, AR, AZ, CA, CO, CT, DC, FL, GA, HI, 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, WA, WI and WV. The countries of Italy, Norway, Austria, Argentina, Bangladesh, Bahrain, Bolivia, Chile, Colombia, Costa Rica, Greece, Ecuador, Israel, Jordan, Kuwait, Niue, Oman, Peru, Philippines, Qatar, Romania, Serbia, Saudi Arabia, United Arab Emirates, Uruguay, Belgium, Netherlands, Luxembourg, China, Croatia, Hungary, Denmark, Iceland, Germany, Spain, India, Japan, United Kingdom, Russia, Australia, New Zealand, Switzerland, France, Czech Republic, Slovakia, South Africa, Poland, Turkey, Georgia, Canada, Sweden, Finland, Kazakhstan, Mexico, South Korea, Singapore, Malaysia, Portugal, Ireland, and Hong Kong.

device · product 2 of 3

Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is also used as spare part.

Z-1857-2021
Recall number
Z-1857-2021
Initiated
April 14, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Radiometer Medical ApS
Quantity
Total=4,135 analyzers world-wide (only 1277 analyzers within the U.S.)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

Code information

Model Number: ABL90 FLEX PLUS (393-092) Serial Numbers: ABL90 FLEX PLUS analyzers serial numbers R0214 R0218, and R0223 onwards

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, AR, AZ, CA, CO, CT, DC, FL, GA, HI, 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, WA, WI and WV. The countries of Italy, Norway, Austria, Argentina, Bangladesh, Bahrain, Bolivia, Chile, Colombia, Costa Rica, Greece, Ecuador, Israel, Jordan, Kuwait, Niue, Oman, Peru, Philippines, Qatar, Romania, Serbia, Saudi Arabia, United Arab Emirates, Uruguay, Belgium, Netherlands, Luxembourg, China, Croatia, Hungary, Denmark, Iceland, Germany, Spain, India, Japan, United Kingdom, Russia, Australia, New Zealand, Switzerland, France, Czech Republic, Slovakia, South Africa, Poland, Turkey, Georgia, Canada, Sweden, Finland, Kazakhstan, Mexico, South Korea, Singapore, Malaysia, Portugal, Ireland, and Hong Kong.

device · product 3 of 3

E3800 PC Units (spare parts)

Z-1858-2021
Recall number
Z-1858-2021
Initiated
April 14, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Radiometer Medical ApS
Quantity
Total 965 PC units World-wide (only 35 units in the U.S.)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to an issue with the internal clock of the analyzers with an e3800 PC unit installed.

Code information

Part number: 910-414

Distribution pattern

Worldwide distribution - U.S. Nationwide distribution in the states of AK, A L, AR, AZ, CA, CO, CT, DC, FL, GA, HI, 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, WA, WI and WV. The countries of Italy, Norway, Austria, Argentina, Bangladesh, Bahrain, Bolivia, Chile, Colombia, Costa Rica, Greece, Ecuador, Israel, Jordan, Kuwait, Niue, Oman, Peru, Philippines, Qatar, Romania, Serbia, Saudi Arabia, United Arab Emirates, Uruguay, Belgium, Netherlands, Luxembourg, China, Croatia, Hungary, Denmark, Iceland, Germany, Spain, India, Japan, United Kingdom, Russia, Australia, New Zealand, Switzerland, France, Czech Republic, Slovakia, South Africa, Poland, Turkey, Georgia, Canada, Sweden, Finland, Kazakhstan, Mexico, South Korea, Singapore, Malaysia, Portugal, Ireland, and Hong Kong.