CLASS II Device recall · Reported 14 Aug 2013 · FDA Enforcement Report
Dimension Exl Loci Module Tshl Flex Reagent Cartridge recalled
Siemens Healthcare Diagnostics is recalling Dimension Exl Loci Module Tshl 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-1883-2013
- 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 EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). 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
Is Dimension Exl Loci Module Tshl Flex Reagent Cartridge ( recalled?
Yes. Siemens Healthcare Diagnostics recalled Dimension Exl Loci Module Tshl Flex Reagent Cartridge ( on 10 May 2013. The recall is Class II and its status is Terminated. Recall number Z-1883-2013.
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 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.
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