CLASS II Device recall · Reported 30 Dec 2015 · FDA Enforcement Report
Reagent Management System (RMS) Dimension RxL Max HM STM recalled
Siemens Healthcare Diagnostics is recalling Reagent Management System (RMS) Dimension RxL Max HM STM, distributed nationwide in the US. The recall was initiated on 10 Nov 2015 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-0461-2016
- FDA event ID
- 72738
- Recalling firm
- Siemens Healthcare Diagnostics, Brookfield, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Nov 2015
- FDA classified
- 21 Dec 2015
- Reported
- 30 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- Test Kits & Diagnostics
Timeline
| 10 Nov 2015 | Recall initiated by company | |
| 21 Dec 2015 | Classified by FDA | +41 days |
| 30 Dec 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management System (RMS) is a module for use with the Dimension¿ clinical chemistry system. The RMS doubles the available storage of refrigerated Flex¿ reagent cartridges on the Dimension¿ system from 44 to 88. The RMS loads, hydrates, and automatically removes Flex¿ reagent cartridges, allowing the Dimension¿ system to process samples without interruption.
Where it was distributed
US Nationwide Distribution: FL, NY, SC, TX, LA, AZ, WI, IA, IL, OH, AL, AK, NH, OK, MD, CA, NM, MS, KY, NJ, MN, GA, CO, MA, SD, TN, MO, PA, MT, SC, NE, KS, VA, AL, NV, WY, OR, PR, MO, OK, GU, HI, AR, ME, VT, CT, NC and the countries of Canada and Mexico.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMaineMinnesotaMissouri
Questions about this recall
Why was it recalled?
Siemens has identified RMS refrigeration compressors that are missing the safety cover on the electrical termination block. The exposed electrical hazard on the electrical termination block is located directly behind the RMS Waste Container.
Which lots are affected?
Dimension RXL MAX HM STM Catalog Numbers 752000.941 (Domestic)/752000.951 (Intl). RMS for RxL Catalog Numbers 753000.901 (Domestic)/753000.902 (Intl). All serial numbers.
Where was it sold?
US Nationwide Distribution: FL, NY, SC, TX, LA, AZ, WI, IA, IL, OH, AL, AK, NH, OK, MD, CA, NM, MS, KY, NJ, MN, GA, CO, MA, SD, TN, MO, PA, MT, SC, NE, KS, VA, AL, NV, WY, OR, PR, MO, OK, GU, HI, AR, ME, VT, CT, NC and the countries of Canada and Mexico.
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
3 other products · FDA event 72738This product is part of a recall event; the main page for the event is Reagent Management System (RMS) Dimension EXL with LM STM recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Reagent Management System (RMS) Dimension EXL with LM STM recalled | Siemens Healthcare Diagnostics | Temperature Abuse | Nationwide | |
| CLASS II | Reagent Management System (RMS) Dimension EXL with LM recalled | Siemens Healthcare Diagnostics | Temperature Abuse | Nationwide | |
| CLASS II | Reagent Management System (RMS) Dimension RxL Max w/o HM recalled | Siemens Healthcare Diagnostics | Temperature Abuse | Nationwide |
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