CLASS II Device recall · Reported 14 Aug 2013 · FDA Enforcement Report
Dimension TSH Flex Reagent Cartridge recalled
Siemens Healthcare Diagnostics is recalling Dimension TSH Flex Reagent Cartridge (, distributed nationwide in the US. The recall was initiated on 10 May 2013 and the FDA has classified it as Class II.
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-1882-2013
- FDA event ID
- 65162
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 May 2013
- FDA classified
- 6 Aug 2013
- Reported
- 14 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 10 May 2013 | Recall initiated by company | |
| 6 Aug 2013 | Classified by FDA | +88 days |
| 14 Aug 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A rare variant of TSH, identified in a small cluster of patients, is not detected.
Product as listed by the FDA
Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Where it was distributed
Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.
Nationwide ArkansasColoradoDelawareIdahoIllinoisIndianaMassachusettsMontanaPennsylvaniaTennessee
Questions about this recall
Why was it recalled?
A rare variant of TSH, identified in a small cluster of patients, is not detected.
Which lots are affected?
Per recall strategy.
Where was it sold?
Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AR, AT, AU, BA, BD, BE, BG, BO, BR, BY, CH, CL, CM, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JO, JP, KA, KR, KW, KZ, LB, LK, LT, LV, LY, MA, MK, MT, MX, MY, NI, NL, NO, NP, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, RU, SA, SE, SG, SK, SV, SY, TH, TM, TN, TR, TW, UA, UY, UZ, VE, VN, XS, and ZA.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 65162This product is part of a recall event; the main page for the event is Immulite Systems Third Generation TSH recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Immulite Systems Third Generation TSH recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Advia Centaur Systems TSH3 Ultra ReadyPack recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Dimension Exl Loci Module Tshl Flex Reagent Cartridge recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Dimension Vista System TSH Flex Reagent Cartridge recalled | Siemens Healthcare Diagnostics | Other | Nationwide | |
| CLASS II | Immulite Systems Rapid TSH recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Other | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein 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 | Potency & Assay | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |