CLASS III Device recall · Reported 5 Jul 2017 · FDA Enforcement Report
Diastat(R) Ana (anti-Nuclear antibody) Euro Diagnostica recalled
Euro Diagnostica AB is recalling Diastat(R) Ana (anti-Nuclear antibody) Euro Diagnostica, The Diastat(R) anti-nuclear, distributed in Minnesota, Nebraska, Pennsylvania, Texas. The recall was initiated on 22 May 2017 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2627-2017
- FDA event ID
- 77426
- Recalling firm
- Euro Diagnostica AB, Malmo, N/A
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 May 2017
- FDA classified
- 23 Jun 2017
- Reported
- 5 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 22 May 2017 | Recall initiated by company | |
| 23 Jun 2017 | Classified by FDA | +32 days |
| 5 Jul 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA, The DIASTAT(R) anti-nuclear antibody (ANA) test is a qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of ANAs in human serum or EDTA plasma. It detects ANAs against Sm, Sm/RNP, Ro (SS-A), La (SS-B), Scl-70, Jo-1, dsDNA, histone and centromere antigens.
Where it was distributed
MN, TX, NE, PA, Spain, Egypt, Pakistan, Nepal, Canada
Questions about this recall
Why was it recalled?
FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date.
Which lots are affected?
TS 3577
Where was it sold?
MN, TX, NE, PA, Spain, Egypt, Pakistan, Nepal, Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Euro Diagnostica AB
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | is a quantitative/qualitative enzyme-linked immunosorbent recalled | Euro Diagnostica AB | Labeling Errors | MN |
| Device | CLASS III | is a qualitative indirect enzyme immunoassay enzyme-linked recalled | Euro Diagnostica AB | Labeling Errors | MN |
| Device | CLASS III | is a quantitative/qualitative enzyme-linked immunosorbent recalled | Euro Diagnostica AB | Labeling Errors | MN |
| Device | CLASS III | is a quantitative/qualitative enzyme-linked immunosorbent recalled | Euro Diagnostica AB | Labeling Errors | MN |
| Device | CLASS II | Immunoscan CCPlus test kit is an enzyme-linked recalled | Euro Diagnostica AB | Potency & Assay | MN, TX |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |