CLASS II Device recall · Reported 25 May 2016 · FDA Enforcement Report
Triple Quad 4500MD LC/MS/MS System recalled by Ab Sciex
Ab Sciex is recalling AB Sciex Triple Quad 4500MD LC/MS/MS System, distributed in North Carolina. The recall was initiated on 25 Mar 2016 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-1671-2016
- FDA event ID
- 73786
- Recalling firm
- Ab Sciex, Framingham, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Mar 2016
- FDA classified
- 15 May 2016
- Reported
- 25 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 25 Mar 2016 | Recall initiated by company | |
| 15 May 2016 | Classified by FDA | +51 days |
| 25 May 2016 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Under certain conditions, mass spectrometers may report incorrect quantitative results.
Product as listed by the FDA
AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QTRAP 4500MD LC/MS/MS System, Part No. 5031231. Mass spectrometers for in vitro diagnostic use only.
Where it was distributed
Distributed to the state of NC.
Questions about this recall
Is Triple Quad 4500MD LC/MS/MS System recalled?
Yes. Ab Sciex recalled Triple Quad 4500MD LC/MS/MS System on 25 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1671-2016.
Why was it recalled?
Under certain conditions, mass spectrometers may report incorrect quantitative results.
Which lots are affected?
Serial Numbers: Triple Quad 4500MD LC/MS/MS System BX21081601 BX21101601 BX21091601 BX21111601 BX21121602 BX21131602 BX21141602 BX21151602 QTRAP 4500MD LC/MS/MS System BW20251601 BW20241601 BW20261602
Where was it sold?
Distributed to the state of NC.
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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