CLASS II ONGOING Device recall · Reported 11 Oct 2023 · FDA Enforcement Report
4500MD Triple Quad Mass Spectrometer recalled by AB Sciex
AB Sciex is recalling 4500MD Triple Quad Mass Spectrometer, distributed nationwide in the US. The recall was initiated on 30 Aug 2023 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-0038-2024
- FDA event ID
- 92810
- Recalling firm
- AB Sciex, Framingham, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Aug 2023
- FDA classified
- 5 Oct 2023
- Reported
- 11 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 30 Aug 2023 | Recall initiated by company | |
| 5 Oct 2023 | Classified by FDA | +36 days |
| 11 Oct 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
4500MD Triple Quad Mass Spectrometer, Part Number 5032522
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
In rare occasions, the combination of a leak of a highly flammable solvent at the ion source probe, and an electrical discharge may result in a flame on top of the probe and possible ejection of the electrode assembly from the probe. There is a risk to the patient/user, customer property, or environment because there is a potential for a health risk and property damage should the flame be left unattended. The failure causes a delay in patient results.
Which lots are affected?
UDI-DI: 00842365102049; Serial Numbers: EJ230051806PL, EJ230061807PL, EJ230071808, EJ230101810, EJ230111811, EJ230121811, EJ230141811, EJ230151812, EJ230161812, EJ230171901, EJ230181901, EJ230191901, EJ230211905, EJ230221908, EJ230231908, EJ230251909, EJ230271910, EJ230281910, EJ230311911, EJ230331912, EJ230362003, EJ230372003, EJ230392004, EJ230412009, EJ230422011, EJ230442012, EJ230452012, EJ230472101, EJ230482103, EJ230512105, EJ240012110, EJ240022111, EJ240052111, EJ240082207, EJ240092209, EJ240142307, EJ240132305, EJ240062201
Where was it sold?
US Nationwide.
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 92810This product is part of a recall event; the main page for the event is Citrine Triple Quad Mass Spectrometer recalled by AB Sciex.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Citrine Triple Quad Mass Spectrometer recalled by AB Sciex | AB Sciex | Packaging Defects | Nationwide | |
| CLASS II | API3200MD Mass Spectrometer recalled by AB Sciex | AB Sciex | Packaging Defects | Nationwide | |
| CLASS II | Citrine Qtrap Mass Spectrometer recalled by AB Sciex | AB Sciex | Packaging Defects | Nationwide |
More recalls from AB Sciex
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citrine Qtrap Mass Spectrometer recalled by AB Sciex | AB Sciex | Packaging Defects | Nationwide |
| Device | CLASS II | API3200MD Mass Spectrometer recalled by AB Sciex | AB Sciex | Packaging Defects | Nationwide |
| Device | CLASS II | Citrine Triple Quad Mass Spectrometer recalled by AB Sciex | AB Sciex | Packaging Defects | Nationwide |
| Device | CLASS II | Cliquid MD recalled by Ab Sciex | AB Sciex | Hidden Drug Ingredients | Nationwide |
| Device | CLASS II | Triple Quad 4500MD LC/MS/MS System recalled by Ab Sciex | Ab Sciex | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |