CLASS II Device recall · Reported 10 Apr 2013 · FDA Enforcement Report
Roche Molecular Systems cobas x 480 System reagent reservoir recalled
Roche Diagnostics Operations is recalling Roche Molecular Systems cobas x 480 System reagent reservoir, distributed nationwide in the US. The recall was initiated on 1 Mar 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-1028-2013
- FDA event ID
- 64453
- Recalling firm
- Roche Diagnostics Operations, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Mar 2013
- FDA classified
- 1 Apr 2013
- Reported
- 10 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Lead & Heavy Metals
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Mar 2013 | Recall initiated by company | |
| 1 Apr 2013 | Classified by FDA | +31 days |
| 10 Apr 2013 | 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
Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System, for in vitro diagnostics.
Where it was distributed
Nationwide Distribution including Puerto Rico and the states of MO, NE, CO, MT, NJ, FL, WA, TX, GA, NY, KS, NH, VA, HI, PA, MI, IA, CA, NC, AZ, UT, LA, IL, TN, ME, MN, KY, CT, OR, NV, AL and NM.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaHawaiiIowaIllinoisKansasKentuckyLouisianaMaineMichiganMinnesotaMissouriMontanaNorth CarolinaNebraska
Questions about this recall
Is Roche Molecular Systems cobas x 480 System reagent reservoir recalled?
Yes. Roche Diagnostics Operations recalled Roche Molecular Systems cobas x 480 System reagent reservoir on 1 Mar 2013. The recall is Class II and its status is Terminated. Recall number Z-1028-2013.
Why was it recalled?
Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent.
Which lots are affected?
Lot / SN : 477415,477416, 477898, and 477899
Where was it sold?
Nationwide Distribution including Puerto Rico and the states of MO, NE, CO, MT, NJ, FL, WA, TX, GA, NY, KS, NH, VA, HI, PA, MI, IA, CA, NC, AZ, UT, LA, IL, TN, ME, MN, KY, CT, OR, NV, AL and NM.
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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